Alocare 1 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Alocare 1 mg film-coated tablets EFG
Finasteride
Read the entire leaflet carefully before taking this medicine.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and you should not give it to others, even if they have the same symptoms, as it may harm them.
- If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Leaflet contents
- What Alocare 1 mg tablets are and what they are used for
- Before you take Alocare 1 mg tablets
- How to take Alocare 1 mg tablets
- Possible side effects
- How to store Alocare 1 mg tablets
- Further information
1. What Alocare 1 mg tablets are and what they are used for
Alocare 1 mg contains an active substance called finasteride. Finasteride belongs to a group of medicines known as 5-alpha reductase inhibitors.
Your doctor has prescribed Alocare 1 mg because you have male pattern hair loss (also known as androgenetic alopecia). Alocare 1 mg helps prevent further hair loss in men. Men with mild to moderate, but not complete, hair loss may benefit from using Alocare 1 mg.
Alocare 1 mg blocks an important enzyme (5α-reductase Type II), which is involved in regulating the hair follicle.
In the scalp, Alocare 1 mg specifically reduces levels of DHT, a primary cause of male pattern hair loss. In this way, Alocare 1 mg helps slow down the process of balding and prevent further hair loss.
2. Before taking Alocare 1 mg tablets
Do not take Alocare 1 mg:
- If you are allergic (hypersensitive) to finasteride or to any of the other components of Alocare 1 mg.
- If you are a child or adolescent.
- If you are a woman (also see the section ‘Pregnancy and breastfeeding’). Clinical studies have shown that Alocare 1 mg is not effective in the treatment of hair loss (androgenetic alopecia) in women.
- If you are already taking finasteride or any other 5α-reductase inhibitor for benign prostatic hyperplasia or for any other condition.
Take special care with Alocare 1 mg:
Serum prostate-specific antigen (PSA) levels should be measured before starting treatment with finasteride and during treatment.
Mood alterations and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Alocare 1 mg. If you experience any of these symptoms, stop taking Alocare 1 mg and consult your doctor as soon as possible.
In some patients, sexual dysfunction has been reported, which may contribute to mood alterations, including suicidal thoughts. If you experience symptoms of sexual dysfunction, contact your doctor for further medical advice. Your doctor may consider discontinuing treatment (see section 4 below for more information on these adverse effects).
A patient information card, reminding of the above information, is provided with the Alocare 1 mg packaging.
Use of other medicines:
Alocare 1 mg generally does not interfere with other medicines. Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
There is no available information on the use of Alocare 1 mg together with topical minoxidil (applied to the skin) in male pattern hair loss.
Use of Alocare 1 mg with food and drinks:
Alocare 1 mg may be taken with or without food.
Pregnancy and breastfeeding:
Alocare 1 mg is intended for use in men only.
Women who are or may be pregnant must not handle Alocare 1 mg tablets, especially if the tablets are broken, split, or crushed. If finasteride is absorbed through the skin or taken orally by a pregnant woman carrying a male fetus, the baby may be born with congenital abnormalities of the genital organs.
If your partner is or may be pregnant, you should avoid exposing her to your semen (e.g. by using a condom) or discontinue treatment with finasteride.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines:
There is no information suggesting that Alocare 1 mg affects the ability to drive or operate machinery.
Important information about some of the components of Alocare 1 mg:
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Alocare 1 mg tablets
Always take Alocare 1 mg exactly as your doctor has instructed you. If you are unsure, consult your doctor or pharmacist.
The usual dose is one tablet daily of Alocare 1 mg.
The coated tablets may be taken either on an empty stomach or with food. The coated tablets must be swallowed whole and must not be split or crushed.
- Alocare 1 mg does not work better or faster if you take more than one tablet per day.
- Male pattern hair loss is a condition that takes a long time to develop.
In general, daily use for three to six months may be necessary before you notice an increase in hair thickness or a reduction in hair loss.
- Your doctor will help you assess whether Alocare 1 mg is producing results. It is important to continue taking Alocare 1 mg for the full duration prescribed by your doctor.
Patients with liver disorders
There is no experience with the use of Alocare 1 mg in patients with liver disorders (see also 'Take special care with Alocare 1 mg').
Patients with renal disorders
Dose adjustment is not necessary in patients with renal disorders.
If you take more Alocare 1 mg than you should:
If you have taken more Alocare 1 mg than prescribed, or if someone else has taken any amount of Alocare 1 mg, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, indicating the medication and the amount ingested. Go to your nearest hospital and bring with you any remaining tablets or the empty packaging to assist with identification.
If you forget to take Alocare 1 mg:
If you forget to take a dose of Alocare 1 mg, continue with your next dose as usual. Do not take a double dose to make up for a missed dose.
If you stop taking Alocare 1 mg:
Continuous use of Alocare 1 mg is recommended to achieve maximum benefit. If treatment is stopped, you are likely to lose the hair regained within the following 9 to 12 months.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Alocare 1 mg may cause adverse effects, although not everyone experiences them.
Usually, adverse effects have been temporary during continued treatment or disappeared once treatment was stopped.
Uncommon (between 1 and 10 in every 1,000 patients):
- decreased sexual desire
- difficulty in achieving an erection
- ejaculation problems such as reduced semen volume.
- depression
Frequency not known:
- allergic reactions such as skin rash, itching, lumps under the skin (urticaria), and swelling of the lips and face
- breast tenderness or swelling
- testicular pain
- increased heart rate
- persistent difficulty in achieving an erection after stopping treatment
- cases of infertility have been reported in men who took finasteride for a long time and who had other risk factors that could affect fertility. Normalization or improvement in semen volume has been reported after discontinuation of finasteride treatment. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
- anxiety
- Suicidal thoughts
Stop your treatment with Alocare 1 mg and consult your doctor immediately if you experience any of the following symptoms:
- swelling of your face, tongue, or throat
- difficulty swallowing
- lumps under the skin (urticaria)
- breathing difficulties
- Suicidal thoughts
If you consider any of the effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
5. Storage of Alocare 1 mg tablets
- Keep out of the reach and sight of children.
- This medicine does not require any special storage conditions.
- Do not use Alocare 1 mg after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
- Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Information for the user
Composition of Alocare 1 mg:
The active substance is finasteride. One tablet contains 1 mg of finasteride.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose (E460), pregelatinized maize starch, sodium starch glycolate from potato (type A), lauroyl macrogol glycerides, magnesium stearate (E572).
Coating: hypromellose (E464), titanium dioxide (E171), macrogol 6000, red iron oxide (E172), yellow iron oxide (E172).
Appearance of the medicinal product and content of the container of Alocare 1 mg:
Film-coated tablet.
Alocare 1 mg tablets are reddish-brown in colour, round, biconvex, marked 'F1' on one side and unmarked on the other.
Alocare 1 mg tablets are packaged in aluminium/aluminium blisters containing 28 and 98 tablets.
Marketing Authorization Holder:
Industrial Farmacéutica Cantabria, S.A.
Barrio Solía 30
La Concha de Villaescusa
39690 Cantabria (Spain)
Manufacturer responsible:
Wessling Hungay KFT.
Foti ut 56. Budapest H1047 Hungary
Vasut u. 13,
Hungary
or
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona, Spain
This leaflet was last approved in November 2025.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.